Important Safety Information

WHAT IS LYNPARZA?

LYNPARZA is a prescription medicine used to treat adults who have:

advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy

advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

It is not known if LYNPARZA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

LYNPARZA may cause serious side effects, including:

Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have ovarian cancer or breast cancer and who have received previous treatment with chemotherapy, radiotherapy, or certain other medicines for their cancer have developed MDS or AML during treatment with LYNPARZA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with LYNPARZA.

Symptoms of low blood cell counts are common during treatment with LYNPARZA, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, feeling very tired, bruising or bleeding more easily.

weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with LYNPARZA until your blood cell counts improve

Lung problems (pneumonitis). Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your healthcare provider may do a chest x-ray if you have any of these symptoms. Your healthcare provider may temporarily or completely stop treatment if you develop pneumonitis. Pneumonitis may lead to death.

Before taking LYNPARZA, tell your healthcare provider about all of your medical conditions, including if you:

have lung or breathing problems

have kidney problems

are pregnant, become pregnant, or plan to become pregnant. LYNPARZA can harm your unborn baby and may cause loss of pregnancy (miscarriage)

If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with LYNPARZA

Females who are able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 6 months after the last dose of LYNPARZA. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant

Males with female partners who are pregnant or able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 3 months after the last dose of LYNPARZA

Do not donate sperm during treatment with LYNPARZA and for 3 months after your final dose

are breastfeeding or plan to breastfeed. It is not known if LYNPARZA passes into your breast milk. Do not breastfeed during treatment with LYNPARZA and for 1 month after receiving the last dose of LYNPARZA. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking LYNPARZA and certain other medicines may affect how LYNPARZA works and may cause side effects.

How should I take LYNPARZA?

Take LYNPARZA tablets exactly as your healthcare provider tells you

Do not change your dose or stop taking LYNPARZA unless your healthcare provider tells you to. Your healthcare provider may temporarily stop treatment with LYNPARZA or change your dose of LYNPARZA if you experience side effects

Your healthcare provider will decide how long you stay on treatment

Do not take more than 4 LYNPARZA tablets in 1 day. If you have any questions about LYNPARZA, talk to your healthcare provider or pharmacist

Take LYNPARZA by mouth 2 times a day

Each dose should be taken about 12 hours apart

Swallow LYNPARZA tablets whole. Do not chew, crush, dissolve, or divide the tablets

Take LYNPARZA with or without food

If you miss a dose of LYNPARZA, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose

If you take too much LYNPARZA, call your healthcare provider or go to the nearest hospital emergency room right away

What should I avoid while taking LYNPARZA?

Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment with LYNPARZA since they may increase the level of LYNPARZA in your blood.

LYNPARZA may cause serious side effects. The most common side effects of LYNPARZA are:

nausea or vomiting. Tell your healthcare provider if you get nausea or vomiting. Your healthcare provider may prescribe medicines to treat these symptoms

low number of red or white blood cells

stomach-area (abdominal) pain

dizziness

tiredness or weakness

sore throat or runny nose

diarrhea

joint, muscle, and back pain

headache

constipation

mouth sores

respiratory tract infections

changes in kidney function blood test

changes in the way food tastes

loss of appetite

low number of platelets

indigestion or heartburn

These are not all the possible side effects of LYNPARZA. Call your healthcare provider for medical advice about side effects.

You may report side effects related to AstraZeneca products by clicking here.

The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions about your condition, or if you would like more information about LYNPARZA, talk to your doctor or pharmacist. Only you and your health care professional can decide if LYNPARZA is right for you.

IMPORTANT SAFETY INFORMATION

Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have ovarian cancer or breast cancer and who have received previous treatment with chemotherapy, radiotherapy, or certain other medicines for their cancer have developed MDS or AML during treatment with LYNPARZA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with LYNPARZA.

Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have ovarian cancer or breast cancer and who have....Read More